Roche won't face competition from biosimilars for a few years, but it's already mapped out a three-prong strategy for a counterattack. In an interview with the Wall Street Journal, Roche CEO Severin Schwan said that the biopharma giant is planning to aggressively develop biobetters, or improvements on existing biologics, along with new products. And the giant drug company will continue to work with BIO to make sure that anyone planning to pick off one of its bio-blockbusters will have to mount expensive new studies in order to gain an approval.
"Eventually the patents will expire; biosimilars will come into the market. What really counts is, you bring in a new product which has a meaningful clinical difference," Schwan told the Journal. First up: Patents for Herceptin and Mabthera, which expire in Europe in 2014 and 2015. Patents for its Avastin franchise start expiring in 2018.
The Wall Street Journal makes the point that generic competition these days quickly drives down price. But it fails to note that few analysts think that market game is going to play out the same way for biosimilars. Most forecasts on the follow-on drug category expect a 10 to 25 percent discount--a reflection of the high cost of copycat studies--leaving biopharma companies with substantial revenue from older products some time after their patents expire.
The Journal story also rolls out the obligatory nod to T-DM1, which failed to gain an early approval. Roche still has plenty of time to conduct all the studies needed for a regulatory approval.
- here's the article from the Wall Street Journal